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Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278067
Recruitment Status : Completed
First Posted : September 11, 2017
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
University of Surrey
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.

Condition or disease Intervention/treatment
Influenza, Human Other: Enhanced vaccine safety surveillance

Detailed Description:
This is the third pilot study following, EPI-FLU-045 VS UK [NCT02567721] and EPI-FLU-046 VS UK [NCT02893878] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.

Layout table for study information
Study Type : Observational
Actual Enrollment : 23939 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Vaccinated_Fluarix Tetra Group
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017.
Other: Enhanced vaccine safety surveillance
Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.
Other Name: Data collection

Vaccinated_Non GSK Group
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017.
Other: Enhanced vaccine safety surveillance
Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.
Other Name: Data collection

Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or non-GSK not known) in 10 volunteer GP practices between 01 September and 30 November 2017.
Other: Enhanced vaccine safety surveillance
Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.
Other Name: Data collection




Primary Outcome Measures :
  1. Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  2. Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  3. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  4. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  5. Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  6. Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  7. Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  8. Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  9. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  10. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  11. Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  12. Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea and, vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  13. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  14. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  15. Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  16. Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  17. Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  18. Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  19. Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  20. Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  21. Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card;
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine.

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  22. Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card;
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine.

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017.


  23. Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  24. Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  25. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  26. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  27. Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  28. Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  29. Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  30. Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  31. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  32. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  33. Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  34. Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  35. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial oedema and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  36. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  37. Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  38. Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  39. Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  40. Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  41. Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  42. Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  43. Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  44. Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  45. Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  46. Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  47. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  48. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  49. Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  50. Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  51. Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  52. Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  53. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  54. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  55. Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  56. Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  57. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  58. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  59. Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  60. Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  61. Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  62. Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  63. Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  64. Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  65. Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  66. Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017



Secondary Outcome Measures :
  1. Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from General Practitioners (GPs). The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  2. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  3. Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  4. Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  5. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  6. Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  7. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  8. Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  9. Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  10. Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  11. Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    SAEs reported here are derived from 2 sources of data - ADR cards and SAE routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  12. Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  13. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    "subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  14. Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  15. Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  16. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  17. Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  18. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  19. Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  20. Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  21. Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  22. Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group [ Time Frame: Within 7 days post vaccination ]

    SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  23. Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  24. Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  25. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years, and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine

    Vaccination of subjects happened between weeks 35 and 48 of the year 2017


  26. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of the year 2017


  27. Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  28. Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  29. Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  30. Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  31. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator = the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator = the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine

    Vaccination happened between weeks 35 and 48, of 2017


  32. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + ADR) within 7 days following vaccination with seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48, 2017


  33. Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  34. Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The cumulative incidence rates of AEIs expressed as a cumulative percentage of subjects, were estimated as follows:

    The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system); The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine.

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  35. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of the year 2017


  36. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of 2017


  37. Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  38. Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  39. Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  40. Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  41. Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of 2017


  42. Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of 2017


  43. Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    "SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017"


  44. Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group [ Time Frame: Within 7 days post vaccination ]

    SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  45. Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  46. Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  47. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  48. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  49. Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  50. Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  51. Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017

  52. Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  53. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  54. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  55. Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  56. Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  57. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  58. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  59. Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  60. Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  61. Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  62. Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  63. Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  64. Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  65. Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017


  66. Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status [ Time Frame: Within 7 days post vaccination ]

    SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017



Biospecimen Retention:   None Retained
Not applicable (no sample)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Registered patients in up to 10 general practices in UK immunized against seasonal influenza at the beginning of 2017/18 season.
Criteria

Inclusion Criteria:

  • All individuals who receive influenza vaccination among the 10 participating GP practices between 1 September and 30 November 2017 are eligible for inclusion in the analysis.

Exclusion Criteria:

  • Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278067


Locations
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United Kingdom
GSK Investigational Site
Surrey, United Kingdom, GU2 7XH
Sponsors and Collaborators
GlaxoSmithKline
University of Surrey
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] June 30, 2017
Statistical Analysis Plan  [PDF] December 11, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03278067    
Other Study ID Numbers: 207781
First Posted: September 11, 2017    Key Record Dates
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
England
Adverse Event of Interest
Seasonal influenza vaccines
Pilot study
Prospective passive enhanced safety surveillance
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases